Treatment Adherence and ComplianceNCT04175860
Adherence to the Transition-discharge-hospital Plan in Patient-family Caregiver With Chronic Pathology
A study testing The intervention with the patient (Chronic Patient Care Group and his family.) in people with Treatment Adherence and Compliance, run by Universidad de Santander at 1 site in Colombia.
Trial summary
To evaluate the therapeutic adherence of the patient-family caregiver with non-communicable chronic disease through the hospital transition-discharge plan program in a second level institution in the metropolitan area of Bucaramanga. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Adherence and Compliance
- What is being tested?
- The intervention with the patient (Chronic Patient Care Group and his family.)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteColombia
- Study dates
- 30 Nov 2019to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with chronic pathology hospitalized in a second level institution in Floridablanca.
- Patient resident in the metropolitan area of Bucaramanga
- Patients over 18 years of age
- Patient with diagnosis at least 6 months old
Who cannot join
- People with communication difficulties.
- Patients with a health condition that at the time of the interview does not allow them to participate in the study.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
ESE Hospital San Juan de Dios Floridablanca
Floridablanca, Santander Department, 681002
Nubia Quintero Lozano, 6750664, nqlquintero@hotmail.com
María S Campos de Aldana, Msc, 3176608313, al.campos@mail.udes.edu.co
About this study
Official title: Design and Evaluation of Adherence to the Transition-discharge-hospital Plan in Patient-family Caregiver With Chronic Pathology in a Health Institution of the Metropolitan Area of Bucaramanga
To evaluate the therapeutic adherence of the patient-family caregiver with non-communicable chronic disease through the hospital transition-discharge plan program in a second level institution in the metropolitan area of Bucaramanga. Methods: The study will be a randomized controlled clinical trial in 100 participants who meet the inclusion criteria, distributed in a 1: 1 ratio for the intervention group and the control group, considering a confidence level of 90%, power of 80% and a reduction of 30%. Expected results: demonstrate the relevance of the program in the target population through the formation of information mechanisms between the parties involved in direct care, the development of skills and safety at home; the timely identification of the risks inherent to clinical conditions or possible complications associated with care, which aim to reduce the burdens related to the health - disease experience; also emphasize the continuity of the treatment established. On the other hand, achieve a more informed professional performance, prepared, transparent, that responds to the needs and expectations of the user in terms of monitoring and comprehensive therapeutic management. Impact: It is expected that this research will be the basis for the protocolization and implementation of the hospital discharge transition plan program in the health institution and subsequently develop a prospective study on a larger scale, which will allow evaluating its impact on the target population in order to reduce the complications, re-admissions and costs derived from the care of chronic patients.
Read the detailed description
Noncommunicable chronic diseases are pathologies that over time require skills in the patient and family caregiver; to ensure safe and continuous care once they are discharged from health institutions. The approach of them represents multiple challenges in need of greater communication and education; for this, the importance of generating strategies through different interventions must be taken into account.
In this order of ideas, the program Plan of discharge or discharge consists of a coordinated intervention and executed by nursing staff that captures the patient dyad with chronic illness-family caregiver from his admission, stay and hospital discharge. The previous approach consists of a systematized guide that contemplates the following activities: 1) assessment of the family caregiver patient dyad to define the competence for care in the home (CARING), the level of risk and complexity of the care associated with the treatment in the home, according to defined risk: polypharmacy, parenteral medications, control medications and / or invasive devices; 2) education and instruction to the patient and the family caregiver during the hospital stay, anticipating the care needs at the time of discharge, with delivery of booklets, brochures and instructions, and 3) telephone follow-up for up to one month, by means of a 2-call call. week. (Melo Melo, Vargas Hernández, Carrrillo, \& Alarcón Trujillo, 2017).
In a study carried out by (Sanchez, Carrillo Gonzalez, \& Barrera, 2014) they refer that there exists a great variety of literature on the plan of transition and hospital discharge, in which it is possible to evidence a heterogeneous level opposite to concrete guidelines, to advance these plans, although this management is recommended in benefit of the users since the evidence on the effectiveness of the development of plans of care, as fundamental part of the continuous, safe and integral care of the patients and their families is very limited.
The support of professionals, institutions and the health system must respond to these demands to ensure the right to quality care for the sick person and the support required by his or her family caregiver, as well as other factors that influence access, security, continuity, social support with the use of appropriate information and communication technology and the strengthening of capacities for self-management and competence for care. (Carrillo Gonzalez , Sanchez Herrera, Gomez, Carreño, \& Chaparro Diaz, 2017).
It is important to highlight that in a study conducted by (Sara Gutiérrez 2014) its objective was to identify the way of educating both the patient and the family at the time of discharge, it was possible to identify that the nursing staff does not give education to patients of the instructions issued by the medical staff; patients and their caregivers do not understand the care received and therefore 86% do not comply with the latest indications as well as 50% of re-entries is given for not having understood or had education in front of the care and instructions given at the time of discharge of the patient. (Gutierrez Suarez \& Freire, 2014).
Regarding Effectiveness of the egress or transition plan for safe, comprehensive and continuous care, a trend is shown that would allow recommending the hospital transition and discharge plan, to support continuity, facilitate change, specify the guideline, avoid complications and decrease avoidable cost in patients with chronic, non-communicable disease. (Gutierrez Suarez \& Freire, 2014)
On the other hand (Ginarte Arias, 2001) comments that in the majority of cases the patient and / or caregiver is blamed in the adherence; However, 'it is suggested that public policies and the health system could be directly related to the cause of non-adherence to treatment.' (Ginarte Arias, 2001) In addition, the weaknesses of the Health System contribute to the problem.
To assess adherence, different instruments have been designed, the most appropriate for this study being the Therapeutic Adherence Scale: it contains three factors, each with seven items distributed as follows: Control over the intake of medicines and foods, Medical follow-up behavioral and self-efficacy. Adherence is measured as a percentage, with 100 patients adhering. In this order of ideas, this instrument allows the evaluation of adherence in chronic diseases, without being directed to a specific disease. On the other hand, the authors have concluded that this scale identifies behavioral characteristics of patients, which favor or not their adherence to treatment (Soria Trujano, Vega Valero, \& Navas Quiroz, 2009).
Program of Transition - Discharge Hospital, is based on strategies that can reduce adherence to treatment being predictive and key factors among which are: 'lack of knowledge of the disease, the therapeutic regimen and the consequences of non-compliance by the patient; lack of an adequate relationship between the patient and the doctor, complexity and long duration of treatment, asymptomatic disease, inadequate follow-up or lack of an elaborate plan on the abandonment of the medication; presence of adverse effects, cost of medication and / or copayment, failure to attend medical appointments, presence of psychological problems such as depression or anxiety, beliefs and perceptions of the patient. The transition and hospital discharge program starts from the patient's admission to hospital. the institution and the medication and presence of cognitive difficulties '. (Dilla, Valladares, Lizán, \& Sacristán, 2009)
This research proposal is in the context and is articulated with the Comprehensive Health Care Policy (PAIS), where it addresses the different actors of the Health System to intervene in the social determinants that promote the health of people with chronic diseases. . It also shows the importance of intervening in public health with programs that in a short period contribute in a concrete way to the operative component in the Model of Integral Health Care (MIAS). (Ministry of Health and Social Protection, 2016)
- Conditions
- Treatment Adherence and Compliance
- Being tested
- The intervention with the patient (Chronic Patient Care Group and his family.)
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intervention with the patient (Chronic Patient Care Group and his family.)Behavioural
- Characterization: through the application of the characterization survey of the dyad (patient-caregiver),
- Evaluation of the competence to care at home: Application of the instrument 'competence to care at home, long and short version both the patient and the family caregiver.
- Risk assessment: this step is made based on the complexity of the treatment and the results of the evaluation the competence to care at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Consists of a series of non-pharmacological preventive interventions that will focus on the - transition-discharge-hospital program including individualized non-pharmacological interventions such as dyad characterization, competency assessment, risk assessment, inherent program strategies, and monitoring.
The intervention or program " Hospital Discharge Plan" to develop was proposed by the Group of Chronic Care Patient and Family School of Nursing at the National University of Colombia. This program includes an educational session and weekly telephone follow-up according to the patient's risk characterization. Receives: Behavioral: The intervention with the patient (Chronic Patient Care Group and his family.) |
| Control group | No intervention | This group of patients-family caregivers will be carried out the discharge activities that are regularly developed in the second level institution and recorded in a check-sheet and field diary. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Adherence to treatment
Scale of therapeutic adherence for patients with chronic diseases, based on explicit behaviors developed by Rocio Soria Trujano, Cynthia Zaira Vega Valero and Carlos Nava Quiroz of the Facultad de Estudios Superiores Iztacala UNAM. Mexico.
Measured: within the first 30 days
Secondary outcomes (1)
1. Competence for care
Caregiver's capacity for care 'developed by the Chronic Patient Care Group and its Family of the Faculty of Nursing of the Universidad Nacional of Colombia. This instrument was developed based on the NOC (Nursing Outcomes Classification) taxonomies related to the preparation for care by the patient with chronic disease and family caregiver.
Measured: within the first 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start30 Nov 2019 (estimated)
- Primary completion30 Nov 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Santander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María S Campos de Aldana, Msc, Principal investigator, Universidad de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175860
- Sponsor's protocol ID
- CIF 0314-19
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Carrillo-González, G. M., Barreto-Osorio, R. V., Arboleda, L. B., Gutiérrez-Lesmes, O. A., Melo, B. G., & Ortiz, V. T. (2015). Competencia para cuidar en el hogar de personas con enfermedad crónica y sus cuidadores en Colombia. Revista de la Facultad de Medicina, 63(4), 665-675.
González, G. M. C., Herrera, B. S., Ramírez, O. J. G., Moreno, S. P. C., & Díaz, L. C. (2017). Metodología de implementación del "plan de egreso hospitalario" para personas con enfermedad crónica en Colombia. Revista Med de la Facultad de Medicina, 25(2), 55-62.
Mabel Carrillo G, Sanchez Herrera B, Arias Rojas EM. Validation of an instrument to assess the homecare competency of the family caregiver of a person with chronic disease. Invest Educ Enferm. 2015 Dec;33(3):449-455. doi: 10.17533/udea.iee.v33n3a08.
PubMed 28569952Dilla T, Valladares A, Lizan L, Sacristan JA. [Treatment adherence and persistence: causes, consequences and improvement strategies]. Aten Primaria. 2009 Jun;41(6):342-8. doi: 10.1016/j.aprim.2008.09.031. Epub 2009 May 7. No abstract available. Spanish.
PubMed 19427071familia, G. d. (s.f.). Bogotá: Universidad Nacional de Colombia. Ginarte Arias, Y. (2001). La adherencia terapéutica. Revista Cubana de Medicina general Integral, 502-505.
Gutierrez Suarez, S., & Freire, C. (2014). Plan de egreso del paciente en el cuidado de enfermeria: cumplimiento en pacientes del área de Medicina Interna del hospita Pablo Arturo Suarez. Chile: Universidad de las americas.
Melo Melo BG, Vargas Hernandez Y, Carrillo GM, Alarcon Trujillo DK. Effect of the programme Plan de egreso on chronically ill patients and their family caregivers. Enferm Clin (Engl Ed). 2018 Jan-Feb;28(1):36-43. doi: 10.1016/j.enfcli.2017.09.006. Epub 2017 Nov 17. English, Spanish.
PubMed 29153438
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Evaluation of Adherence to the Transition-discharge-hospital Plan in Patient-family Caregiver With Chronic Pathology in a Health Institution of the Metropolitan Area of Bucaramanga
- ClinicalTrials.gov ID
- NCT04175860
- Acronym / sponsor ID
- CIF 0314-19
- Conditions
- Treatment Adherence and Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de SantanderUniversity, hospital or other
- Study start
- 30 Nov 2019 (estimated)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the therapeutic adherence of the patient-family caregiver with non-communicable chronic disease through the hospital transition-discharge plan program in a second level institution in the metropolitan area of Bucaramanga. Methods: The study will be a randomized controlled clinical trial in 100 participants who meet the inclusion criteria, distributed in a 1: 1 ratio for the intervention group and the control group, considering a confidence level of 90%, power of 80% and a reduction of 30%. Expected results: demonstrate the relevance of the program in the target population through the formation of information mechanisms between the parties involved in direct care, the development of skills and safety at home; the timely identification of the risks inherent to clinical conditions or possible complications associated with care, which aim to reduce the burdens related to the health - disease experience; also emphasize the continuity of the treatment established. On the other hand, achieve a more informed professional performance, prepared, transparent, that responds to the needs and expectations of the user in terms of monitoring and comprehensive therapeutic management. Impact: It is expected that this research will be the basis for the protocolization and implementation of the hospital discharge transition plan program in the health institution and subsequently develop a prospective study on a larger scale, which will allow evaluating its impact on the target population in order to reduce the complications, re-admissions and costs derived from the care of chronic patients.
Detailed description
Noncommunicable chronic diseases are pathologies that over time require skills in the patient and family caregiver; to ensure safe and continuous care once they are discharged from health institutions. The approach of them represents multiple challenges in need of greater communication and education; for this, the importance of generating strategies through different interventions must be taken into account.
In this order of ideas, the program Plan of discharge or discharge consists of a coordinated intervention and executed by nursing staff that captures the patient dyad with chronic illness-family caregiver from his admission, stay and hospital discharge. The previous approach consists of a systematized guide that contemplates the following activities: 1) assessment of the family caregiver patient dyad to define the competence for care in the home (CARING), the level of risk and complexity of the care associated with the treatment in the home, according to defined risk: polypharmacy, parenteral medications, control medications and / or invasive devices; 2) education and instruction to the patient and the family caregiver during the hospital stay, anticipating the care needs at the time of discharge, with delivery of booklets, brochures and instructions, and 3) telephone follow-up for up to one month, by means of a 2-call call. week. (Melo Melo, Vargas Hernández, Carrrillo, \& Alarcón Trujillo, 2017).
In a study carried out by (Sanchez, Carrillo Gonzalez, \& Barrera, 2014) they refer that there exists a great variety of literature on the plan of transition and hospital discharge, in which it is possible to evidence a heterogeneous level opposite to concrete guidelines, to advance these plans, although this management is recommended in benefit of the users since the evidence on the effectiveness of the development of plans of care, as fundamental part of the continuous, safe and integral care of the patients and their families is very limited.
The support of professionals, institutions and the health system must respond to these demands to ensure the right to quality care for the sick person and the support required by his or her family caregiver, as well as other factors that influence access, security, continuity, social support with the use of appropriate information and communication technology and the strengthening of capacities for self-management and competence for care. (Carrillo Gonzalez , Sanchez Herrera, Gomez, Carreño, \& Chaparro Diaz, 2017).
It is important to highlight that in a study conducted by (Sara Gutiérrez 2014) its objective was to identify the way of educating both the patient and the family at the time of discharge, it was possible to identify that the nursing staff does not give education to patients of the instructions issued by the medical staff; patients and their caregivers do not understand the care received and therefore 86% do not comply with the latest indications as well as 50% of re-entries is given for not having understood or had education in front of the care and instructions given at the time of discharge of the patient. (Gutierrez Suarez \& Freire, 2014).
Regarding Effectiveness of the egress or transition plan for safe, comprehensive and continuous care, a trend is shown that would allow recommending the hospital transition and discharge plan, to support continuity, facilitate change, specify the guideline, avoid complications and decrease avoidable cost in patients with chronic, non-communicable disease. (Gutierrez Suarez \& Freire, 2014)
On the other hand (Ginarte Arias, 2001) comments that in the majority of cases the patient and / or caregiver is blamed in the adherence; However, 'it is suggested that public policies and the health system could be directly related to the cause of non-adherence to treatment.' (Ginarte Arias, 2001) In addition, the weaknesses of the Health System contribute to the problem.
To assess adherence, different instruments have been designed, the most appropriate for this study being the Therapeutic Adherence Scale: it contains three factors, each with seven items distributed as follows: Control over the intake of medicines and foods, Medical follow-up behavioral and self-efficacy. Adherence is measured as a percentage, with 100 patients adhering. In this order of ideas, this instrument allows the evaluation of adherence in chronic diseases, without being directed to a specific disease. On the other hand, the authors have concluded that this scale identifies behavioral characteristics of patients, which favor or not their adherence to treatment (Soria Trujano, Vega Valero, \& Navas Quiroz, 2009).
Program of Transition - Discharge Hospital, is based on strategies that can reduce adherence to treatment being predictive and key factors among which are: 'lack of knowledge of the disease, the therapeutic regimen and the consequences of non-compliance by the patient; lack of an adequate relationship between the patient and the doctor, complexity and long duration of treatment, asymptomatic disease, inadequate follow-up or lack of an elaborate plan on the abandonment of the medication; presence of adverse effects, cost of medication and / or copayment, failure to attend medical appointments, presence of psychological problems such as depression or anxiety, beliefs and perceptions of the patient. The transition and hospital discharge program starts from the patient's admission to hospital. the institution and the medication and presence of cognitive difficulties '. (Dilla, Valladares, Lizán, \& Sacristán, 2009)
This research proposal is in the context and is articulated with the Comprehensive Health Care Policy (PAIS), where it addresses the different actors of the Health System to intervene in the social determinants that promote the health of people with chronic diseases. . It also shows the importance of intervening in public health with programs that in a short period contribute in a concrete way to the operative component in the Model of Integral Health Care (MIAS). (Ministry of Health and Social Protection, 2016)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: The intervention with the patient (Chronic Patient Care Group and his family.)Consists of a series of non-pharmacological preventive interventions that will focus on the - transition-discharge-hospital program including individualized non-pharmacological interventions such as dyad characterization, competency assessment, risk assessment, inherent program strategies, and monitoring. The intervention or program " Hospital Discharge Plan" to develop was proposed by the Group of Chronic Care Patient and Family School of Nursing at the National University of Colombia. This program includes an educational session and weekly telephone follow-up according to the patient's risk characterization. |
| Control group | No intervention | –This group of patients-family caregivers will be carried out the discharge activities that are regularly developed in the second level institution and recorded in a check-sheet and field diary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient with chronic pathology hospitalized in a second level institution in Floridablanca.
- Patient resident in the metropolitan area of Bucaramanga
- Patients over 18 years of age
- Patient with diagnosis at least 6 months old
Key exclusion criteria (2 listed)
- People with communication difficulties.
- Patients with a health condition that at the time of the interview does not allow them to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The intervention with the patient (Chronic Patient Care Group and his family.)* Characterization: through the application of the characterization survey of the dyad (patient-caregiver), * Evaluation of the competence to care at home: Application of the instrument 'competence to care at home, long and short version both the patient and the family caregiver. * Risk assessment: this step is made based on the complexity of the treatment and the results of the evaluation the competence to care at home. | Behavioural | Intervention group |
Primary outcome
1. Adherence to treatment
Time frame: within the first 30 days
Scale of therapeutic adherence for patients with chronic diseases, based on explicit behaviors developed by Rocio Soria Trujano, Cynthia Zaira Vega Valero and Carlos Nava Quiroz of the Facultad de Estudios Superiores Iztacala UNAM. Mexico.
1 secondary outcome
1. Competence for care
Time frame: within the first 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- BackgroundCarrillo-González, G. M., Barreto-Osorio, R. V., Arboleda, L. B., Gutiérrez-Lesmes, O. A., Melo, B. G., & Ortiz, V. T. (2015). Competencia para cuidar en el hogar de personas con enfermedad crónica y sus cuidadores en Colombia. Revista de la Facultad de Medicina, 63(4), 665-675.
- BackgroundGonzález, G. M. C., Herrera, B. S., Ramírez, O. J. G., Moreno, S. P. C., & Díaz, L. C. (2017). Metodología de implementación del "plan de egreso hospitalario" para personas con enfermedad crónica en Colombia. Revista Med de la Facultad de Medicina, 25(2), 55-62.
- Background: PubMed 28569952Mabel Carrillo G, Sanchez Herrera B, Arias Rojas EM. Validation of an instrument to assess the homecare competency of the family caregiver of a person with chronic disease. Invest Educ Enferm. 2015 Dec;33(3):449-455. doi: 10.17533/udea.iee.v33n3a08.
- Background: PubMed 19427071Dilla T, Valladares A, Lizan L, Sacristan JA. [Treatment adherence and persistence: causes, consequences and improvement strategies]. Aten Primaria. 2009 Jun;41(6):342-8. doi: 10.1016/j.aprim.2008.09.031. Epub 2009 May 7. No abstract available. Spanish.
- Backgroundfamilia, G. d. (s.f.). Bogotá: Universidad Nacional de Colombia. Ginarte Arias, Y. (2001). La adherencia terapéutica. Revista Cubana de Medicina general Integral, 502-505.
- BackgroundGutierrez Suarez, S., & Freire, C. (2014). Plan de egreso del paciente en el cuidado de enfermeria: cumplimiento en pacientes del área de Medicina Interna del hospita Pablo Arturo Suarez. Chile: Universidad de las americas.
- Background: PubMed 29153438Melo Melo BG, Vargas Hernandez Y, Carrillo GM, Alarcon Trujillo DK. Effect of the programme Plan de egreso on chronically ill patients and their family caregivers. Enferm Clin (Engl Ed). 2018 Jan-Feb;28(1):36-43. doi: 10.1016/j.enfcli.2017.09.006. Epub 2017 Nov 17. English, Spanish.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María S Campos de Aldana, Msc principal investigator
Universidad de Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intervention with the patient (Chronic Patient Care Group and his family.) in people with Treatment Adherence and Compliance, run by Universidad de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María S Campos de Aldana, Msc (3176608313 ext. 1221, al.campos@mail.udes.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Adherence to treatment (time frame: within the first 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04175860, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.